Method of applying defibrillator electrode pad with folded release sheet

ABSTRACT

A defibrillator electrode pad assembly has an adhesive release sheet configured to be removed while the electrode pad is held in a desired position on the patient. The release sheet is folded in a substantially U-shaped configuration and includes a pull-tab to be grasped by the user. The electrode pad is applied to the patient by positioning the electrode pad on the patient&#39;s skin with the release sheet facing the skin and in contact with or closely adjacent to the skin, without lifting the electrode pad from the patient&#39;s skin, pulling on the pull-tab to remove the release sheet to expose the adhesive portion, and adhering the adhesive portion to the patient&#39;s skin.

TECHNICAL FIELD

This invention relates to skin-applied electrode pads, e.g., for usewith defibrillators.

BACKGROUND

Skin-applied electrode pads are well known for use in medicalapplications such as cardiac pacing, ECG monitoring, and defibrillation.Typically, these electrode pads are attached to a wire lead or cablethat is attached at its opposite end to the connector of a medicaldevice or medical device instrumentation. Electrode pads generallyinclude an electrode, e.g., a conductor such as a thin layer of tin oranother metal, resting on a foam backing. The electrode typically iscovered with a conductive gel that contacts a patient's skin andelectrically connects the electrode to the patient, and the electrodepad includes a ring of adhesive surrounding the conductive gel to adherethe electrode to the patient's skin.

For one or more reasons, e.g., to prevent the adhesive gel from dryingout, to maintain the electrodes in a sanitary condition, and to coverthe adhesive until a caregiver is ready to adhere the electrode to thepatient, a release sheet, e.g., a plastic cover, is positioned over theadhesive and/or conductive gel of each electrode.

To use the electrode pads, a caregiver connects the wire leads to anappropriate medical device such as a defibrillator (if they are notpre-connected), removes the release sheets from the electrode pads, andapplies the electrode pads to the patient. If the caregiver does notcorrectly position the electrode pads on the first try, it may bedifficult to reposition the electrode pads if the adhesive has adheredto the patient's skin. If the caregiver is able to remove and repositionthe electrodes, adhesion may not be as good as it would have been hadthe electrode pads not been previously adhered. Also, if the electrodesare large in size and flexible, some of the electrode's adhesivesurfaces may inadvertently adhere to each other during handling of the(release sheetless) electrode requiring the clinician to separate thestuck together portions prior to application to the patient. This“untangling” of the electrode can be frustrating, time consuming,difficult and may degrade the electrode's ability to adhere to thepatient.

SUMMARY

Generally, the invention features an electrode pad in which an adhesivearea is covered by a release sheet that is configured to be removedwhile the release sheet is in contact with or closely adjacent to apatient's skin. This arrangement allows the caregiver to carefullyposition the electrode pad with the release sheet in place, and thenremove the release sheet without moving the electrode pad.

Because the release sheet can be removed from the electrode pad afterthe electrode pad has been properly positioned, without moving theelectrode pad, accurate and precise placement can be achieved. Moreover,the need to remove, reposition and attempt to re-adhere an electrode padthat has already adhered to a patient's skin is eliminated and thelikelihood that the electrode's adhesive surfaces will stick togetherduring application is reduced. The time saved can literally be thedifference between life and death in an emergency situation. Forexample, when defibrillation is required, every second of delay inapplying the electrode pads can be critical.

In one aspect, the invention features a generally planar skin-appliedelectrode pad including: (a) an electrode, (b) an adhesive configured toadhere the electrode to a patient's skin, and (c) a release sheet, afirst portion of the release sheet covering the adhesive, and a secondportion of the release sheet extending from the first portion and beingfolded so that the release sheet can be peeled away from the adhesive bypulling the second portion in a direction substantially parallel to theplane of the electrode pad.

Some implementations may include one or more of the following features.The electrode pad includes a conductive gel, and the conductive gel iscovered by the release sheet. The adhesive is non-conductive. Theadhesive surrounds the gel. The release sheet is folded in asubstantially U-shaped configuration. An edge of the second portion ofthe release sheet extends beyond an adjacent edge of the electrode,providing a pull-tab that can be grasped during removal of the releasesheet. The release sheet is selected from the group consisting ofrelease-coated papers, plastic sheet materials and polymeric films. Theelectrode pad includes a cable constructed to connect the electrode padto a defibrillator control box. The electrode pad is configured for usewith an automatic external defibrillator (AED), or a manual orsemi-automatic external defibrillator.

In another aspect, the invention features a skin-applied electrode padhaving a release sheet that is configured to be removed while theelectrode pad is held in a desired position on the patient with aportion of the release sheet in contact with the patient's skin.

The invention also features, in another aspect, a defibrillatorincluding a skin-applied electrode pad of the invention.

Some implementations may include one or more of the following features.The defibrillator is an automatic external defibrillator. Two or moreelectrode pads are integrally connected, forming an electrode padassembly. The release sheet is folded in a substantially U-shapedconfiguration. An edge of the second portion of the release sheetextends beyond an adjacent edge of the electrode, providing a pull-tabthat can be grasped during removal of the release sheet.

In yet another aspect, the invention features a method of applying anelectrode to a patient, the electrode including an adhesive portioncovered by a release sheet. The method includes (a) positioning theelectrode on the patient's skin with the release sheet facing the skinand in contact with or closely adjacent to the skin, (b) without liftingthe electrode from the patient's skin, removing the release paper toexpose the adhesive portion, and (c) adhering the adhesive portion tothe patient's skin.

Other features and advantages of the invention will be apparent from thedetailed description and drawings, and from the claims.

DESCRIPTION OF DRAWINGS

FIG. 1 is a top view of a prior art electrode pad.

FIG. 2 is a cross-sectional view of an electrode pad according to oneembodiment of the invention. FIGS. 2A and 2B are similar cross-sectionalviews, illustrating removal of the release sheet.

FIG. 3 is a drawing of an electrode pad assembly according to oneembodiment of the invention, positioned over the chest of a patient.

FIG. 4 is a cross-sectional view of an electrode pad according to analternate embodiment of the invention.

FIG. 5 is a back planar view of an electrode pad similar to that shownin FIG. 2.

DETAILED DESCRIPTION

An electrode pad 10 is shown in FIG. 1. When in use, electrode pad 10 isconnected to a defibrillator control box 13 (not shown to scale) bycable 11.

Electrode pad 10 is relatively large, rendering it suitable for use indefibrillation. Typically, the surface area of electrode pad 10 is atleast 50 cm², more preferably from about 50 cm² to 100 cm². Smallermedical electrodes, such as EKG electrodes, are generally much easier toplace than the large defibrillator electrodes described above. This isin part due to the flexibility of the electrode, which makes theelectrode difficult to control after the release paper is removed andcan result in the sticking together problem discussed above in theBackground.

Referring to FIG. 2, electrode pad 10 includes an electrode 12, aconductive gel layer 14, an adhesive ring 15, and a release sheet 16.Optionally, electrode pad 10 may include a stabilizing tab 18 (not shownin FIG. 1), the function of which will be described below. Electrode 12includes a foam backing or other suitable backing material (not shown),as is well known.

Release sheet 16 is folded, at fold 20, to define a generally U-shapedconfiguration, defining a portion 17 that is initially adhered to theadhesive and gel, and a portion 19 that extends freely beyond fold 20.The release sheet is folded in a manner so that it will not unfold toany significant extent during storage or prior to use. As shown in FIGS.5 and 5A, the release sheet may also be held in place by a pair of tabs25 extending from portion 17, under which pull tab 26 is disposed priorto use. Alternatively, a small area of pressure sensitive adhesive canbe positioned in the same general area, on portion 17 or portion 19, toadhere the two portions together until use. Referring to FIG. 2, the end22 of the release sheet that is adjacent the gel layer 14 is generallysubstantially aligned with the edge 23 of the electrode pad. Theopposite end 24 of the release sheet extends beyond the edge 23 of theelectrode pad, providing a pull-tab 26 which can be grasped by a user.Pull tab 26 preferably extends far enough beyond the edge 23 to providea good grasp between the thumb and forefinger, typically at least about1 inch.

To apply electrode pad 10 to a patient, a caregiver positions theelectrode pad on the patient's chest in a desired position. When thecaregiver is sure that the electrode pad is in the correct position, thecaregiver holds the electrode pad in place, e.g., by graspingstabilizing tab 18, grasps pull tab 26, and peels the release sheet 16out from underneath the electrode pad as indicated by arrow A in FIG. 2.Grasping stabilizing tab 18 while pulling on the pull tab 26 stabilizesthe electrode and helps the caregiver to maintain the electrode in thedesired position on the patient as the release sheet is removed. Ifstabilizing tab 18 is omitted, the same result may be obtained bylightly pressing the far side of the electrode (the side opposite thepull tab) against the patient while pulling the pull tab.

As the release sheet 16 is peeled off (FIGS. 2A and 2B), the fold 20moves across the electrode pad in the direction of arrow A, so that thegel layer 14 is exposed and brought into contact with the patient'sskin. As the gel layer and adhesive are exposed, the electrode padadheres to the patient's skin and electrical contact is established.Light pressure may be applied to the electrode pad by the caregiver toensure good adhesion.

The release sheet may be a release-coated paper, a plastic sheetmaterial (including non-polymeric films having the properties ofplastics), a polymeric film, or any other suitable sheet material havingrelease properties sufficient to release from the gel layer andadhesive. Suitable sheet materials for use in the embodiment describedabove are also foldable. Examples of suitable sheet materials includepolystyrene, polyester and paper.

Other embodiments are within the scope of the following claims. Forexample, the electrode pad may have any desired shape and size,including square, circular, or oval.

The adhesive ring may be formed of a non-conductive or conductiveadhesive, and the adhesive may be provided in any other desired shape orconfiguration.

The electrode pad may be integrally attached to one or more otherelectrode pads to form an electrode pad assembly, allowing a pair ofelectrodes to be easily applied to a patient, e.g., as disclosed incopending U.S. Ser. No. 09/794,320, filed Feb. 27, 2001, the completedisclosure of which is incorporated herein by reference. Such anelectrode pad assembly is shown in FIG. 3. Referring to FIG. 3,electrode pad assembly 110 includes a pair of electrode pads 112, 114.Electrode pad assembly 110 is connected by a cable 111 to aresuscitation control box (not shown). In this case, the pull-tabs 126of the two electrode pads 112, 114 extend from opposite edges 123 a, 123b of the electrode pad assembly so that they are exposed for use.

Moreover, the electrode pad or electrode pad assembly may include textor other indicia to help a caregiver locate the electrode, e.g., asdisclosed in U.S. Ser. No. 09/794,320.

In another embodiment, shown in FIG. 4, an electrode pad 200 includes apair of U-folded release sheets 216 a, 216 b. Each release sheet isfolded at a fold 220 (220 a, 220 b), to define a generally U-shapedconfiguration. The end 222 of each release sheet that is adjacent thegel layer 14 is generally substantially aligned with the edge 23 of theelectrode pad. The opposite end 224 of each release sheet extends beyondthe edge 23 of the electrode pad, providing a pull-tab 226 which can begrasped by a user. This option may be desirable when the electrode iscircular or oval.

Portion 19 of the release sheet may be any desired shape. For example,portion 19 may be tapered as shown in FIG. 5. This taper facilitatesremoval of portion 19 and pull tab 26 from the tabs 25.

1-11. (canceled)
 12. The method of claim 26 wherein the electrode padassembly further comprises a conductive gel at the skin contacting areaof each electrode.
 13. The method of claim 12 wherein the adhesive areaof each electrode comprises a non-conductive adhesive.
 14. The method ofclaim 13 wherein the adhesive area surrounds the gel. 15-16. (canceled)17. The method of claim 26 wherein the defibrillator electrodes are forconnection to an automatic, semi-automatic or manual externaldefibrillator. 18-20. (canceled)
 21. The method of claim 26 wherein therelease sheets are configured so that, as the release sheets are peeledaway, a fold about which the release sheet is folded travels in thedirection in which the release sheet is pulled. 22-25. (canceled)
 26. Amethod for applying a defibrillation electrode pad assembly to apatient, comprising removing an electrode pad assembly from a package,the electrode pad assembly comprising first and second electrodes, eachof the electrodes sized and configured for external defibrillation, andeach of the electrodes having a skin-contacting area of at least 50centimeters squared; a non-electrode area positioned between the firstand second electrodes and mechanically connected to the first and secondelectrodes; an electrical cable extending from the electrode padassembly for connecting the electrodes to a defibrillator; an adhesivearea at each of the first and second electrode, the adhesive areaconfigured to adhere an electrode to the skin of the patient, theadhesive area at the first electrode being separated from the adhesivearea at the second electrode by an area without adhesive, and at leastone release sheet covering each adhesive area, each release sheet beingfolded in a substantially U-shaped configuration, each release sheethaving a tab sized and configured to be grasped by one hand of the userwhile the electrode pad assembly is positioned on the chest of thepatient, and each release sheet being configured to be removed by theuser pulling on the tab in a direction generally away from thenon-electrode area, thereby causing the release sheet to peel away fromthe adhesive area, applying the electrode pad assembly to the patient bypositioning the first and second electrodes in the desired position onthe chest, holding the assembly in the desired position by applyingpressure with one hand generally in the non-electrode area, usinganother hand to pull on the tab of the release sheet at the firstelectrode, with the pulling being in a direction generally away from thenon-electrode area, to thereby remove the release sheet from the firstelectrode, repeating the process of holding the assembly in the desiredposition by applying pressure with one hand generally in thenon-electrode area, and using another hand to pull on the tab of therelease sheet at the second electrode, with the pulling being in adirection generally away from the non-electrode area, to thereby removethe release sheet from the second electrode.